Mehren Christoph, Suchomel Petr, Grochulla Frank, Barsa Pavel, Sourkova Petra, Hradil Jan, Korge Andreas, Mayer H Michael
Spine Center Munich, Orthozentrum, Munich, Germany.
Spine (Phila Pa 1976). 2006 Nov 15;31(24):2802-6. doi: 10.1097/01.brs.0000245852.70594.d5.
Prospective clinical study enrolled in 2 centers (Munich and Liberec) as part of a prospective European multicenter study with ProDisc C (Synthes Inc., Paoli, PA).
The first goal of the study was to evaluate the rate of heterotopic ossifications identified with plain radiograph following total cervical disc replacement (TCDR). The second goal was to show whether segmental motion can be preserved, and whether TCDR can provide improvement of the patient's ability to perform activities of daily living as well as a decrease of pain.
Only a few reports about the radiologic outcome after TCDR are published so far. Heterotopic ossification is a well-known phenomenon after total hip arthroplasty. The rate of heterotopic ossification following TCDR is unclear.
The radiographs of 54 patients (in total, 77 implanted prostheses) were analyzed 1 year after TCDR with a ProDisc C prosthesis. We classified the heterotopic ossification in 5 grades according to a recently published classification system for lumbar total disc replacement. For clinical parameters, the visual analog scale and the Neck Disability Index were evaluated preoperatively and 1 year postoperatively. The Student t test and Wilcoxon test were used for statistical analysis.
In 26 treated segments (33.8%), no heterotopic ossification was detectable. Grade 1 ossifications were present in 6 levels (7.8%). A total of 30 segments (39.0%) showed grade 2 ossifications. Heterotopic ossifications that led to restrictions of the range of motion were present in 8 cases (10.4%). One year postoperatively, 7 cases (9.1%) had a spontaneous fusion of the treated segment. The clinical parameters improved significantly and were similar to previous reports about TCDR.
Only 33.8% of the patients did not show any signs of heterotopic ossification, and the rate of spontaneous fusion after TCDR 1 year after surgery was unexpectedly high. There were 49.4% of the patients with grade 2-3 ossification, which lets us suspect an even higher rate of spontaneous fusion after long-term follow-ups. Motion preservation after TCDR is only guaranteed if spontaneous fusion can be prevented. Thus, mobility of the implanted segments needs to be further studied.
作为一项针对ProDisc C(美国宾夕法尼亚州波利市的Synthes公司)的前瞻性欧洲多中心研究的一部分,在2个中心(慕尼黑和利贝雷茨)开展了一项前瞻性临床研究。
本研究的首要目标是评估全颈椎间盘置换术(TCDR)后通过X线平片确定的异位骨化发生率。第二个目标是证明是否能保留节段运动,以及TCDR是否能改善患者的日常生活活动能力并减轻疼痛。
迄今为止,关于TCDR后影像学结果的报道较少。异位骨化是全髋关节置换术后的一种常见现象。TCDR后异位骨化的发生率尚不清楚。
对54例患者(共植入77个假体)在使用ProDisc C假体进行TCDR术后1年的X线片进行分析。根据最近发表的腰椎全椎间盘置换分类系统,将异位骨化分为5个等级。对于临床参数,术前和术后1年评估视觉模拟量表和颈部功能障碍指数。采用Student t检验和Wilcoxon检验进行统计分析。
在26个治疗节段(33.8%)中,未检测到异位骨化。6个节段(7.8%)出现1级骨化。共有30个节段(39.0%)表现为2级骨化。导致运动范围受限的异位骨化有8例(10.4%)。术后1年,7例(9.1%)治疗节段出现自发融合。临床参数有显著改善,与先前关于TCDR的报道相似。
仅33.8%的患者未表现出任何异位骨化迹象,且TCDR术后1年的自发融合率出乎意料地高。有49.4%的患者出现2 - 3级骨化,这让我们怀疑长期随访后自发融合率会更高。只有防止自发融合,才能保证TCDR后的运动保留。因此,需要进一步研究植入节段的活动度。